The following data is part of a premarket notification filed by Jiangsu Ideal Medical Science & Technology Co., Lt with the FDA for Ideal Locking Plate System.
Device ID | K141825 |
510k Number | K141825 |
Device Name: | IDEAL Locking Plate System |
Classification | Plate, Fixation, Bone |
Applicant | JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT 503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD Shanghai, CN 200233 |
Contact | Alice Gong |
Correspondent | Alice Gong JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT 503 ROOM, 8 BLDG, 600 LIU ZHOU ROAD Shanghai, CN 200233 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-07 |
Decision Date | 2015-03-03 |
Summary: | summary |